Saturday, September 12, 2015

To perform activity of Microbiology section of Quality Control Department.To prepare Media, Working Culture, Pure Culture and perform Growth Promotion Test.
To install and execute qualification of Instruments/Equipment/System related to Microbiology section of Quality Control Department.
To analyse water samples as per Performance Qualification Protocol as well as routine monitoring of water quality.
To prepare Specifications, Method of Analysis, Method validation protocol and report, Standard Operating Procedure as per requirement.
Area Qualification and routine microbial monitoring of critical areas.
To review and perform Method Validation, Hold Time Validation Study and Media Fill Protocols and Reports. To ensure compliance of Current GLP & GDP in Microbiology Section.
To prepare documents and reports of microbiology section.
To perform and review Calibration of instruments of microbiology section.
To maintain Biological Indicators, Pure Cultures as well as organism isolated from environment. To maintain and procure essential spares, consumables, media, reagent, glasswares to minimize the delay and maintain inventory and issuance record.
To prepare Quality Performance Indicators like Trend Analysis of microbial monitoring data.
To carry out investigation in case of Out of Trend and Out of Specification Results to find out root cause of the failure and prevent re-occurrence of the failure.
Identification & maintenance of bacterial library by using BBL crystal.To perform & Review personnel qualification.
To Review all the documents of daily monitoring like temperature, pressure, cleaning, disinfectant preparation, discarding, washed garments, environment monitoring.
Sampling of water samples, API, In-process samples, sterile bulk solution.
Maintain stock of all materials used in microbiology department.
Handling of deviation, incident, excursion, change control and breakdown intimation procedure. Testing of Sterility, Bacterial endotoxin, and Liquid particle count for In-process and Finish product samples.
Carrying out vender audit, self-inspection and monitoring the compliance to action plans evolved therein.
To prepare, review and updating training schedule, training matrix, training questionnaire and training sequential log.
To impart SOP and process related training to Quality control, Quality assurance and Production department personnel.
To qualifying the microbiologist by performing their Analyst qualification and gowning qualification.
To facing the internal, contract giver and regulatory audit and give its compliance.